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Last Updated: March 29, 2020

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Niraparib tosylate - Generic Drug Details

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What are the generic drug sources for niraparib tosylate and what is the scope of patent protection?

Niraparib tosylate is the generic ingredient in one branded drug marketed by Tesaro Inc and is included in one NDA. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Niraparib tosylate has two hundred and thirty-nine patent family members in forty-nine countries.

Summary for niraparib tosylate
International Patents:239
US Patents:5
Tradenames:1
Applicants:1
NDAs:1
Bulk Api Vendors: 32
Clinical Trials: 1
Patent Applications: 7
DailyMed Link:niraparib tosylate at DailyMed
Recent Clinical Trials for niraparib tosylate

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SponsorPhase
National Cancer Institute (NCI)Phase 2
University of California, DavisPhase 2
Janssen, LPPhase 2

See all niraparib tosylate clinical trials

Synonyms for niraparib tosylate
(S)-2-(4-(piperidin-3-yl)phenyl)-2H-indazole-7-carboxamide 4-?methylbenzenesulfona?te
(S)-2-(4-(Piperidin-3-yl)phenyl)-2H-indazole-7-carboxamide 4-methylbenzenesulfonate
1038915-73-9
2-{4-[(3S)-piperidin-3-yl]phenyl}-2H-indazole-7-carboxamide; 4-methylbenzene-1-sulfonic acid
2H-Indazole-7-carboxamide, 2-(4-(3S)-3-piperidinylphenyl)-, 4-methylbenzenesulfonate (1:1)
75KE12AY9U
AC-30383
AS-56981
AX8326059
CS-2283
HY-10619B
KS-00000TSH
MK 4827 tosylate
MK-4827 (tosylate)
MK-4827 tosylate
mk-4827-niraparib-tosylate
MK-4827-tosylate
MK-4827(Niraparib) tosylate
Niraparib (MK-4827) tosylate
Niraparib tosylate, MK 4827 tosylate
Niraparib; 4-methylbenzene-1-sulfonic acid
Niraparib(MK-4827) tosylate
Q27266392
s7625
SB16549
SCHEMBL20522624
UNII-75KE12AY9U

US Patents and Regulatory Information for niraparib tosylate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Tesaro Inc ZEJULA niraparib tosylate CAPSULE;ORAL 208447-001 Mar 27, 2017 RX Yes Yes   Start Trial   Start Trial   Start Trial
Tesaro Inc ZEJULA niraparib tosylate CAPSULE;ORAL 208447-001 Mar 27, 2017 RX Yes Yes   Start Trial   Start Trial   Start Trial
Tesaro Inc ZEJULA niraparib tosylate CAPSULE;ORAL 208447-001 Mar 27, 2017 RX Yes Yes   Start Trial   Start Trial   Start Trial
Tesaro Inc ZEJULA niraparib tosylate CAPSULE;ORAL 208447-001 Mar 27, 2017 RX Yes Yes   Start Trial   Start Trial   Start Trial
Tesaro Inc ZEJULA niraparib tosylate CAPSULE;ORAL 208447-001 Mar 27, 2017 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for niraparib tosylate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1633724 C01633724/01 Switzerland   Start Trial PRODUCT NAME: OLAPARIB; REGISTRATION NO/DATE: SWISSMEDIC 65160 14.01.2016
2109608 2018/019 Ireland   Start Trial PRODUCT NAME: NIRAPARIB OR A PHARMACEUTICALLY ACCEPTABLE SALT, STEREOISOMER OR TAUTOMER THEREOF, PARTICULARLY THE TOSYLATE OR A HYDRATE, ESPECIALLY THE TOSYLATE MONOHYDRATE.; REGISTRATION NO/DATE: EU/1/17/1235 20171116
2109608 LUC00072 Luxembourg   Start Trial PRODUCT NAME: NIRAPARIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE, STEREOISOMERE OU TAUTOMERE DE CELUI-CI, NOTAMMENT LE TOSYLATE OU UN HYDRATE, PARTICULIEREMENT LE TOSYLATE MONOHYDRATE; AUTHORISATION NUMBER AND DATE: EU/1/17/1235 20171120
2109608 2018016 Norway   Start Trial PRODUCT NAME: NIRAPARIB ELLER ET; REG. NO/DATE: EU/1/17/1235 20171127
1633724 PA2015016,C1633724 Lithuania   Start Trial PRODUCT NAME: OLAPARIBAS IR JO DRUSKOS IR SOLVATAI; REGISTRATION NO/DATE: EU/1/14/959 20141216
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Johnson and Johnson
Harvard Business School
Colorcon
Merck
McKesson

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.